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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / October 2026 / K261943

510(k) cleared

REMEX-T(K)100C

Remedi, Inc. · Oct 2, 2026 · K261943

FDA cleared the REMEX-T(K)100C from Remedi, Inc. on Oct 2, 2026 under K261943, a traditional 510(k). The device falls under product code IZL, System, X-Ray, Mobile, regulated at 21 CFR 892.1720 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jun 10, 2026. The decision came 114 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Remedi, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261943?

K261943 is the FDA 510(k) for REMEX-T(K)100C, submitted by Remedi, Inc.. FDA's decision date was Oct 2, 2026, under product code IZL (System, X-Ray, Mobile).

Who makes the REMEX-T(K)100C?

Remedi, Inc., based in Seoul, is the applicant of record for K261943.

How long did the K261943 review take?

FDA received the submission on Jun 10, 2026 and issued its decision on Oct 2, 2026, 114 days later.

← All decisions in October 2026